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  • 1.  GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2021 08:44
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    I would like to understand the application of GSPR clause 10.4. Are all clauses under 10.4 applicable to only invasive devices? (device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;). If the device in non-invasive but it comes in contact with the user (not the patient) will 10.4 clauses still apply?


    GSPR clause 10.4.1:

    Devices, or those parts thereof or those materials used therein that:

    •  are invasive and come into direct contact with the human body,
    • (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
    • transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,

    shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:

    Thanks



  • 2.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    Posted 12-Jul-2021 15:09
    I think there is a good possibility that GSPR clause 10.4.1's reference both to "invasive" and to "come into direct contact with the human body" may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an invasive device that doesn't somehow directly contact the human body.  In an explanation from BSI, they seem to have interpreted devices that are "invasive and come into direct contact with the human body" to simply mean invasive devices (see https://www.google.com/search?q=gspr+10.4.1&rlz=1C1CHBF_enUS847US847&oq=gspr+10.4.1&aqs=chrome..69i57j33i160.4523j0j15&sourceid=chrome&ie=UTF-8).

    I recommend consulting the responsible notified body (if any is involved) to understand its particular interpretation.

    Yet because it also seems that CMR and ED substances could reasonably be of concern regarding any device that directly contacts the human body, I've been recommending that non-invasive direct contacting device manufacturers go ahead and complete the chemical review just to be safe unless more definitive direction is available for a particular case.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    Posted 12-Jul-2021 15:50
    Forgot to mention that I'm also sensitive to GSPR 23.4(s) which calls for IFU precautions where appropriate related to the presence of CMR and ED substances and the potential for device materials to cause sensitization or allergic reaction by the patient or user.  Europe's liberal stance on toxicants such as CMR and ED doesn't seem to leave room for excluding users from considerations about the risks of CMR and ED substances.  This would seem to further push the GSPR 10.4.1 interpretation toward including non-invasive direct contacting devices.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 4.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    Posted 13-Jul-2021 01:41
    I agree with Kevin's 3rd para.  I have always taken it to also apply to non invasive devices as well as invasive devices because of CMR & ED.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 5.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jul-2021 08:08
    This message was posted by a user wishing to remain anonymous

    Thanks, Kevin. I was also thinking about the considerations where user is included. This is very helpful.
    Original Message


  • 6.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    Posted 13-Jul-2021 08:16

     

     

    Hi Kevin,

     

    Is it possible that "an invasive device that doesn't somehow directly contact the human body" could be indirect contacting devices like the drug delivery devices described in the second two sub-bullets of 10.4.1?  The third sub-bullet in particular describes drug container closure systems (CCS) for which chemical characterization in the form of extractables and leachables testing is commonly expected.

     

    Best regards,

     

    Ted

     

     

     




    Original Message


  • 7.  RE: GSPR clause 10.4 ON SUBSTANCES applicable to non-invasive devices

    Posted 13-Jul-2021 12:44
    Edited by Kevin Randall 13-Jul-2021 12:48
    Howdy Ted!  My current interpretation is that the second two sub-bullets of 10.4.1 are aimed at the indirect contact route (specifically, certain permutations of indirect contact), whereas the first sub-bullet is reserved for the direct contact route.  I base this on the first sub-bullet's mention of "direct contact" with the human body, and that the European EU MDR authors seem to distinguish between direct contact and indirect contact (as evidenced by the separate dedication to indirect contact in the second two sub-bullets).  I would be surprised if they were lumping indirectly-invasive or indirect-contacting devices into the first sub-bullet; this is because if they were, then it would seem there would be no need for the second two sub-bullets.  Hope that makes sense.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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